NDA 020834

JOHNSON AND JOHNSON

FDA Drug Application

Application #020834

Documents

• Letter: 2003-02-14
• Letter: 2005-06-07
• Letter: 2015-04-29
• Label: 2015-04-29
• Review: 2003-08-08
• Letter: 2004-06-30
• Letter: 2006-09-20
• Label: 2003-05-29

Application Sponsors

NDA 020834

JOHNSON AND JOHNSON

Marketing Status

• Over-the-counter: 001

Application Products

001

SOLUTION;TOPICAL

5%

1

ROGAINE EXTRA STRENGTH (FOR MEN)

MINOXIDIL

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1997-11-14	STANDARD
LABELING; Labeling	SUPPL	3	AP	2003-02-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2004-06-25	STANDARD
LABELING; Labeling	SUPPL	9	AP	2005-05-31	STANDARD
LABELING; Labeling	SUPPL	11	AP	2006-09-12	STANDARD
LABELING; Labeling	SUPPL	14	AP	2015-04-27	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	7	Null	0
SUPPL	14	Null	6

CDER Filings

JOHNSON AND JOHNSON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20834
            [companyName] => JOHNSON AND JOHNSON
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROGAINE EXTRA STRENGTH (FOR MEN)","activeIngredients":"MINOXIDIL","strength":"5%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/27\/2015","submission":"SUPPL-14","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020834Orig1s014lbl.pdf\"}]","notes":""},{"actionDate":"02\/14\/2003","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/020834s003lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ROGAINE EXTRA STRENGTH (FOR MEN)","submission":"MINOXIDIL","actionType":"5%","submissionClassification":"SOLUTION;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2015-04-27
        )

)